Kyverna Therapeutics, Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited interim condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our audited financial statements and related notes thereto as of and for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in Part II, Item 8 of the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. See also the section below titled “Special Note Regarding Forward-Looking Statements.”

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited interim condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our audited financial statements and related notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in Part II of the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission, or the SEC, on March 27, 2025. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. See also the section below titled “Special Note Regarding Forward-Looking Statements.”

Previous wording

our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act or a smaller reporting company; and

Current wording

our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act or a smaller reporting company;

Previous wording

estimates of our expenses, capital requirements and needs for additional financing.

Current wording

estimates of our expenses, capital requirements and needs for additional financing; and

Previous wording

We are a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our goal is to bring disease-modifying therapeutic benefits to patients suffering from autoimmune diseases through our patient-centered approach, our broad platform, our insights into treating immune disorders and the learnings from successful application of cell therapy in other areas of medicine. Our cell therapy approach to the treatment of autoimmune diseases is supported by the scientific publication of multiple autoimmune case studies using CD19 CAR T-cell treatment as well as early clinical data from our ongoing trials illustrating the disease-modifying potential of these therapies. This validation provides us with a clear path to continue advancing our lead product candidate, KYV-101, through clinical development across two broad areas of autoimmune disease: rheumatology and neurology.

Current wording

We are a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. Our goal is to liberate patients from autoimmune diseases through the curative potential of cell therapy. Our approach is supported by our breadth of experience treating patients with our lead product candidate, KYV-101, across more than 15 autoimmune disease indications. This has been documented through the scientific publication of multiple autoimmune case studies, our proprietary dataset of patients treated through named patient forms of compassionate use, our experience in ongoing investigator-initiated trials at leading academic institutions, as well as early clinical data from our ongoing company-sponsored trials illustrating the potential of these therapies to deeply deplete B cells with the aim of achieving durable treatment-free remission. This validation provides us with a clear path to continue advancing KYV-101 through late-stage clinical development and commercialization across two broad areas of autoimmune disease: neuroinflammation and rheumatology.

Previous wording

Our lead program, KYV-101, is an autologous CD19 CAR T-cell product candidate made from an underlying chimeric antigen receptor, or CAR, that we have licensed from the National Institutes of Health, or the NIH. This underlying CAR in KYV-101 has completed a 20-patient Phase 1 trial in oncology conducted by the NIH, and the results from this Phase 1 trial published in Nature Medicine reported improved tolerability in the clinic among adult oncology patients using the same CAR construct in KYV-101, as compared to the CAR used to create Yescarta®. This underlying CAR in KYV-101 was designed by the NIH to improve tolerability through a systematic comparison of CARs created with alternate domain structures, identifying the use of a fully human CD19 binding domain and optimized hinge and transmembrane domains. We believe that these differentiated properties of the underlying CAR construct in KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

Current wording

Our lead program, KYV-101, is an autologous, fully human CD19 CAR T-cell product candidate incorporating highly potent CD28 co-stimulation. KYV-101 is made from an underlying chimeric antigen receptor, or CAR, licensed from the National Institutes of Health, or the NIH. We believe that this uniquely designed CAR in KYV-101 has the potential to deliver a differentiated therapeutic profile in autoimmune disease. In addition to a fully human scFv domain, the CAR in KYV-101 was also designed with a human CD8α hinge and transmembrane domain, a human CD28 costimulatory domain, and a human CD3ζ activation domain. This same underlying CAR in KYV-101 has completed a 20-patient Phase 1 trial in oncology conducted by the NIH, and the results from this Phase 1 trial published in Nature Medicine reported similar rates of durable antitumor responses while delivering improved tolerability in the clinic among adult oncology patients, as compared to the CAR used to create Yescarta®. We believe that these differentiated properties of the CAR in KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., or Gilead, which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering (the “IPO”) in February 2024. Our net losses were $34.5 million and $90.0 million for the three and nine months ended September 30, 2024, respectively, compared with $15.5 million and $39.7 million net losses for the three and nine months ended September 30, 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $226.0 million. Management has determined that our cash and cash equivalents and available-for-sale marketable securities of $321.6 million as of September 30, 2024 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. We have funded our operations primarily from sales of our redeemable convertible preferred stock, issuances of convertible notes, revenue from our collaboration agreement with Gilead Sciences, Inc., which terminated effective as of January 22, 2024, and from the sale of shares of our common stock in our initial public offering, or the IPO, in February 2024. Our net loss was $44.6 million for the three months ended March 31, 2025, compared with $26.7 million net loss for the three months ended March 31, 2024. As of March 31, 2025, we had an accumulated deficit of $308.2 million. Management has estimated that our cash and cash equivalents and available-for-sale marketable securities of $242.6 million as of March 31, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. We plan to monitor expenses and raise additional capital through equity or debt financings, strategic alliances or licensing arrangements. Our ability to access capital when needed is not assured and if capital is not available to us when, and in the amounts, needed, we could be required to delay, scale back or abandon some or all of our development programs and other operations, which could materially harm our business, financial condition and results of operations.

Previous wording

continue to progress the development of our product candidates, including KYV-101 in multiple clinical trials in parallel and KYV-201 into the clinic;

Current wording

continue to progress the development of our product candidates, including KYV-101 in multiple clinical trials in parallel;

Previous wording

We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our drug candidates in accordance with the U.S. Food and Drug Administration’s, or the FDA’s, current Good Manufacturing Practices regulations for use in our clinical studies. In March 2022, we entered into a master services agreement with WuXi ATU Advanced Therapies, Inc., or WuXi. WuXi’s facility in Philadelphia, Pennsylvania, provides us with certain customized cell manufacturing, release and testing services for our KYV-101 product candidate. Pursuant to our Licence and Supply Agreement with Oxford Biomedica (UK) Limited, or Oxford, dated September 2023, we recently engaged Oxford to undertake lentiviral vector process development services, with the intention for Oxford to ultimately manufacture and supply to us lentiviral vectors for research and development purposes and for use in connection with our clinical trials. In July 2023, we entered into a Development and Manufacturing Services Agreement with ElevateBio Base Camp, Inc., or ElevateBio, pursuant to which ElevateBio is undertaking process development services for the development of a low-cost, fully closed manufacturing process for our CAR T-cell product candidates.

Current wording

We do not currently own or operate any manufacturing facilities. We rely on contract manufacturing organizations, or CMOs, to produce our drug candidates in accordance with the FDA’s current Good Manufacturing Practices regulations for use in our clinical studies. In March 2025 the FDA confirmed our planned CMC package to support commercial manufacturing of KYV-101 for SPS and MG as well as future indications, with extensive CMC experience in autoimmune disease from KYSA studies, IITs and compassionate-use cases supporting process characterization. We have supplied clinical product from two clinical manufacturing sites for which the FDA accepted comparability data between manufacturing sites in April 2025. Under our Development and Manufacturing Services Agreement, dated July 2023, or the Elevate Agreement, with ElevateBio Base Camp, Inc., or Elevate, we engaged Elevate in November 2024 to provide us with cell manufacturing, release and testing services for our KYV-101 product candidate. In March 2022, we entered into a master services agreement with Advanced Therapies, Inc., or Advanced Therapies. Advanced Therapies’ facility in Philadelphia, Pennsylvania, provides us with certain customized cell manufacturing, release and testing services for our KYV-101 product candidate. Pursuant to our License and Supply Agreement with Oxford Biomedica (UK) Limited, or Oxford, dated September 2023, we engaged Oxford to undertake lentiviral vector process development services, with the intention for Oxford to ultimately manufacture and supply to us lentiviral vectors for research and development purposes and for use in connection with our clinical trials.

Previous wording

The largest component of our total operating expenses since inception has been research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits for research and development employees, including stock-based compensation; expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that conduct preclinical and clinical studies; costs of acquiring and manufacturing clinical study materials and other supplies; payments under licensing and research and development agreements; other outside services and consulting costs; and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred.

Current wording

The largest component of our total operating expenses since inception has been research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that conduct preclinical and clinical studies; manufacturing process development activities and costs of acquiring and manufacturing clinical study materials and other supplies; payments under licensing and research and development agreements; other outside services and consulting costs; compensation and benefits for research and development employees, including stock-based compensation; and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred. Our internal research and development employees are shared across multiple programs and are not solely dedicated to individual programs. Other research and development expenses primarily include license fees, professional services, unallocated CRO and CMO costs and allocated overhead and facilities expenses.

Previous wording

External research and development costs include:

Current wording

External research and development expenses related to our KYV-101 program increased by $11.1 million or 101% from $11.0 million in 2024 to $22.1 million in 2025 as we continued advancing our lead product candidate, KYV-101, through clinical development. This increase is mainly driven by $8.0 million of strategic investment in CMC readiness to support commercial readiness for SPS and MG, as well as a $4.4 million increase in CRO costs primarily due to accelerated enrollment in our KYSA trials. The increase in KYV-101 CMO and CRO costs was partially offset by a $0.7 million reduction in professional services.

Previous wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through September 30, 2024, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock of $168.0 million, issuances of convertible notes of $2.0 million, an upfront payment of $17.5 million under the Gilead Agreement and net proceeds from the IPO of $336.2 million. As of September 30, 2024, we had $321.6 million in cash, cash equivalents and available-for-sale marketable securities.

Current wording

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. Through March 31, 2025, we have primarily funded our operations from sales of shares of our redeemable convertible preferred stock of $168.0 million, issuances of convertible notes of $2.0 million, an upfront payment of $17.5 million under the Gilead Agreement and net proceeds from the IPO of $336.2 million. As of March 31, 2025, we had $242.6 million in cash, cash equivalents and available-for-sale marketable securities.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. As of September 30, 2024, we had an accumulated deficit of $226.0 million. Based on the current cash forecast, management has determined that our cash and cash equivalents and available-for-sale marketable securities of $321.6 million as of September 30, 2024 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. As of March 31, 2025, we had an accumulated deficit of $308.2 million. Based on the current cash forecast, management has determined that our cash, cash equivalents and available-for-sale marketable securities of $242.6 million as of March 31, 2025 will be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report on Form 10-Q. This forecast of cash resources and planned operations involves risks and uncertainties, and the actual amount of expenses could vary materially as a result of a number of factors.

Previous wording

the cost of filing and prosecuting our patent applications, and maintaining and enforcing our patents and other intellectual property rights;

Current wording

litigation expenses we incur to defend against any claims, including the cost of filing and prosecuting our patent applications, and maintaining and enforcing our patents and other intellectual property rights;

Previous wording

Net cash used in operating activities was $77.2 million and $33.8 million for the nine months ended September 30, 2024 and 2023, respectively.

Current wording

Net cash used in operating activities was $44.9 million and $25.5 million for the three months ended March 31, 2025 and 2024, respectively.

Previous wording

Cash used in operating activities for the nine months ended September 30, 2024, was primarily due to our net loss of $90.0 million, decreased by non-cash charges of 5.0 million and decreased by a net reduction of $7.8 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a $7.0 million stock-based compensation expense, a $1.9 million non-cash lease expense and a $1.6 million depreciation and amortization expense, partially offset by $5.4 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in accounts payable of $6.0 million, an increase in other current liabilities of $3.3 million, an increase in accrued compensation of $1.6 million, partially offset by a decrease in operating lease liability of $1.8 million, an increase in in other non-current assets of $0.9 million and an increase in prepaid expense and other current assets of $0.7 million.

Current wording

Cash used in operating activities for the three months ended March 31, 2025, was primarily due to our net loss of $44.6 million, decreased by non-cash charges of $1.9 million and increased by $2.2 million for changes in our net operating assets and liabilities. The non-cash charges primarily consisted of a $2.2 million stock-based compensation expense, a $0.7 million non-cash lease expense, a $0.6 million impairment charge of a capitalized software and a $0.5 million depreciation and amortization expense, partially offset by $2.1 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease in other current liabilities of $2.3 million, a decrease in accrued compensation of $1.8 million, a decrease in operating lease liability of $1.0 million, an increase in other non-current assets of $0.5 million and an increase in prepaid expense and other current assets of $0.4 million offset by an increase in accounts payable of $3.8 million.

Previous wording

Cash used in operating activities for the nine months ended September 30, 2023, was primarily due to our net loss of $39.7 million, decreased by non-cash charges of $3.4 million and decreased by a net increase of $2.4 million in our net operating assets and liabilities. Non-cash changes primarily consisted of a $1.4 million stock-based compensation expense, a $1.3 million non-cash lease expense and a $1.2 million depreciation and amortization expense, partially offset by $0.5 million of income related to the accretion of discounts on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in other liabilities of $2.3 million, an increase in accounts payable of $1.1 million as we increased our operations and spending and an increase in accrued compensation of $0.4 million, offset by a $1.2 million decrease in operating lease liability and a $0.2 million increase in prepaid expense and other current assets.

Current wording

Cash used in operating activities for the three months ended March 31, 2024, was primarily due to our net loss of $26.7 million, decreased by other non-cash charges of $3.0 million and increased by a net reduction of $1.8 million in our net operating assets and liabilities. Non-cash changes primarily consisted of a $2.3 million stock-based compensation expense, a $0.5 million depreciation and amortization expense and a $0.5 million non-cash lease expense, partially offset by a $0.3 million accretion of discount on available-for-sale marketable securities. The change in our net operating assets and liabilities was primarily due to an increase in prepaid other current assets of $2.6 million, a $1.4 million decrease in accrued compensation, a decrease in operating lease liabilities of $0.5 million, an increase in other non-current assets of $0.3 million and a $0.1 million decrease in other accrued expenses and current liabilities, offset by an increase in accounts payable of $3.1 million.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2023, was $40.5 million, which consisted of $53.9 million of purchases of available-for-sale marketable securities and $0.3 million of purchases of property and equipment, offset by $13.7 million in proceeds from maturities of available-for-sale marketable securities.

Current wording

Net cash provided by investing activities for the three months ended March 31, 2025, was $5.6 million, which consisted of $86.7 million in proceeds from maturities of available-for-sale marketable securities, offset by $81.1 million of purchases of available-for-sale marketable securities.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2024, was $190.1 million, which consisted of $362.8 million of purchases of available-for-sale marketable securities and $1.7 million of purchases of property and equipment, offset by $174.3 million in proceeds from maturities of available-for-sale marketable securities.

Current wording

Net cash used in investing activities for the three months ended March 31, 2024, was $122.9 million, which consisted of $145.3 million of purchases of available-for-sale marketable securities and $0.5 million of purchases of property and equipment, offset by $23.0 million in proceeds from maturities of available-for-sale marketable securities.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2024, was $337.3 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and $0.2 million of proceeds from exercises of stock options, partially offset by $3.4 million payments for deferred offering costs and a payment of $0.7 million related to finance lease obligations.

Current wording

Net cash provided by financing activities for the three months ended March 31, 2024, was $338.0 million, which consisted of $341.2 million cash proceeds from the issuance of shares of our common stock in the IPO, net of underwriting discount and less than $0.1 million of proceeds from exercises of stock options, partially offset by $3.0 million payments for deferred offering costs and a payment of $0.2 million related to finance lease obligations.

Previous wording

We have milestone, royalty and other payments due to third parties under our existing license and collaboration agreements. Refer to Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q for additional details. We cannot estimate when such payments will be due and none of these events were probable to occur as of September 30, 2024, except for the sublicensing fee under our Kite Agreement as discussed in Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q under “Kite License Agreement (Related Party)”.

Current wording

We have milestone, royalty and other payments due to third parties under our existing license and collaboration agreements. Refer to Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q for additional details. We cannot estimate when such payments will be due and none of these events were probable to occur as of March 31, 2025. As of March 31, 2025, and December 31, 2024, we recognized a sublicensing fee of $6.3 million in our condensed balance sheets related to the fee due under our Kite Agreement as discussed in Note 6 to our condensed financial statements included in this Quarterly Report on Form 10-Q.

Previous wording

As of September 30, 2024, we leased approximately 68,000 square feet of office and laboratory space in Emeryville, California under operating leases which have terms through February 2027. We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of September 30, 2024, our non-cancellable lease obligations were $8.9 million and $1.3 million under operating and finance leases, respectively, of which $3.0 million and $0.9 million related to operating and finance leases, respectively, are due within the next 12 months.

Current wording

As of March 31, 2025, we leased approximately 68,000 square feet of office and laboratory space in Emeryville, California under operating leases which have terms through February 2027. We also have multiple leases for laboratory equipment with 36-month terms that are accounted for as finance leases. As of March 31, 2025, our non-cancellable lease obligations were $6.9 million and $0.6 million under operating and finance leases, respectively, of which $3.4 million and $0.5 million related to operating and finance leases, respectively, are due within the next 12 months.

Previous wording

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Current wording

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Our significant accounting policies and critical accounting estimates are described in Note 2 to our audited financial statements for the year ended December 31, 2023 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 26, 2024. There have been no material changes to our significant accounting policies or critical accounting estimates during the nine months ended September 30, 2024, except the fair value of our common stock is the closing price per share on NASDAQ at the grant date for stock-based awards granted as of and subsequent to the IPO.

Current wording

Our significant accounting policies and critical accounting estimates are described in Note 2 to our audited financial statements for the year ended December 31, 2024 included in Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025. There have been no material changes to our significant accounting policies or critical accounting estimates during the three months ended March 31, 2025.

Previous wording

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (a) are no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our condensed financial statements may not be comparable to those of companies that comply with the new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.

Current wording

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (a) are no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our condensed financial statements may not be comparable to those of companies that comply with the new or revised accounting pronouncements as of public company effective dates. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.